Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
CETYLPYRIDINIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ( AS MONOHYDRATE)
RAFA LABORATORIES LTD
R02AD02
LOZENGES
CETYLPYRIDINIUM CHLORIDE 1.25 MG; LIDOCAINE HYDROCHLORIDE ( AS MONOHYDRATE) 1 MG
PER OS
Not required
RAFA LABORATORIES LTD, JERUSALEM
LIDOCAINE
For the relief of severe sore throat. Relief of mouth and throat infections.
2020-02-03
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold without a doctor's prescription KALGARON MINT KALGARON STRAWBERRY KALGARON ORANGE LOZENGES ACTIVE INGREDIENTS: Each lozenge contains: Cetylpyridinium chloride (CPC) 1.25 mg and Lidocaine hydrochloride 1 mg. For a list of the other ingredients, see section 6. See also 'Important information about some of the medicine's ingredients in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. Use this medicine according to the instructions in the dosage section in this leaflet. Consult your pharmacist if you require additional information. Refer to your doctor if the symptoms do not improve within 5 days, if they get worse or if you experience new symptoms. This medicine is not intended for children under 6 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for the relief of severe sore throat and for relief of mouth and throat infections. THERAPEUTIC GROUP: Cetylpyridinium chloride - quaternary ammonium antiseptic. Lidocaine - local anesthetic. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • If you are sensitive (allergic) to the active ingredients, to other anesthetics substances, to quaternary ammonium antiseptics, or to any of the other ingredients the medicine contains (for a list of the other ingredients, see section 6). • In children aged under 6. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: • The anesthetic action of the medicine may interfere with swallowing and may cause inhalation of food (aspiration) during the meal (may be expressed as coughing), or cause you to bite your tongue. Therefore caution should be taken when using it. Likewise, do not use the medicine before eating or drinking. See also 'Use of the medicine and food' section. • Do not use for more then 5 consecutive days, since this may Pročitajte cijeli dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT KALGARON MINT KALGARON ORANGE KALGARON STRAWBERRY LOZENGES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The tablet contains cetylpyridinium chloride (CPC) 1.25 mg and lidocaine hydrochloride 1 mg. For the complete list of the excipients, see section 6.1. 3. PHARMACEUTICAL FORM: Lozenges 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of severe sore throat. Relief of mouth and throat infections. 4.2. DOSAGE AND METHOD OF ADMINISTRATION Oral. For adults and children over the age of 6 years. DOSAGE One tablet to be sucked every 3 to 4 hours: • Adults: do not take more than 6 tablets a day. • Children from 6 to 15 years of age: do not take more than 4 tablets a day. METHOD OF ADMINISTRATION Suck the tablet slowly. Do not crunch or swallow it. Wait at least 2 hours between tablets. Do not take the tablet near to meal times. 4.3. CONTRAINDICATIONS Children under the age of 6 years. Kalgaron is contraindicated in case of known hypersensitivity to antiseptics in the quaternary ammonium class, local anesthetics or one of the excipients indicated in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE 2 WARNINGS Possibility of swallowing the wrong way on account of anesthetizing of the junction between the digestive tract and the respiratory system: • Use this medicine carefully in children under the age of 12 years. • Do not use this medicine before meals or before drinking. The indication is for a treatment lasting no more than 5 days since it might expose to an imbalance of the normal microbial flora of the mouth cavity with risk of bacterial or fungal dissemination. Repeated or prolonged treatment on the mucous membrane may expose to the risk of toxic systemic effects of contact anesthetics (impairing of the central nervous system with convulsions, depression of the cardiovascular system). • Kalgaron Mint contains about 12 mg of lactose. Patients with rare hereditary problems of galactose intolerance, total lactase Pročitajte cijeli dokument